Zogenix Inc. has submitted an investigational new drug (IND) application to the U.S. Food & Drug Administration (FDA) for Relday, a combination of Zogenix’s DosePro needle-free, subcutaneous drug delivery system, plus a proprietary, subcutaneous once-monthly formulation of risperidone for treating schizophrenia. In July 2011, Zogenix licensed from DURECT exclusive global rights to develop and commercialize this proprietary formulation, which utilizes DURECT’s SABER depot technology. Initial clinical trials are currently planned to begin in the second half of the year, with results expected by year-end.
Risperidone is one of the most widely prescribed medications used to treat the symptoms of schizophrenia in adults and teenagers 13 years of age and older. The global long-acting injectable antipsychotic market was approximately $2 billion in 2011, with currently approved products using a 21-gauge or larger needle for intramuscular injections. The leading product in the category requires twice-a-month dosing and drug reconstitution prior to use. The combined market for oral and injectable antipsychotic products was estimated at more than $16 billion in 2010.
If approved, Relday will be the first subcutaneous, needle-free antipsychotic product that allows for once-monthly dosing. Zogenix believes that Relday will offer an improved pharmacokinetic profile, significant reduction in injection volume and a simplified dosing regimen due to DURECT’s SABER controlled-release formulation technology in combination with Zogenix’s DosePro needle-free subcutaneous drug delivery system.
The DosePro system includes a pre-filled, single dose of liquid drug, and is administered subcutaneously, without a needle.
Release Date: May 30, 2012
Source: Zogenix Inc.